Z-1428-2025Class II

namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit

Name: Z-1428-2025 namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2025-02-12
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-02-12 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit on 2025-02-12. FDA classified it as Class II and gives the reason as "The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1428-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-12
Posted: 2025-03-21
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
Product code: DRI Monitor, Line Isolation
Reason for recall: The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: Medline Industries issued two notices, delivered using email and US Mail: 1) a MEDICAL DEVICE RECALL notice for the affected Pressure Monitoring Lines and 2) a MEDICAL DEVICE RECALL notice for the kits containing the affected product; both notices explained the issue and the hazard. The MEDICAL DEVICE RECALL notice for the affected Pressure Monitoring Lines requested that the consignee destroy any affected inventory and reply to receive credit. The MEDICAL DEVICE RECALL notice for the kits containing the affected product requested the consignee respond to the notice and upon response, Medline will provide labeling that states the following: "ATTENTION This kit contains a recalled item Medline Pressure Monitoring Lines VPN: 24614303 DO NOT USE THIS COMPONENT The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*" Consignees were directed to notify their customers of these actions.
Quantity in commerce: 4400 units
Distribution: Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia
Product codes and lots: UDI/DI 10193489067507 (each), 20193489067504 (case), Lot number 0000140528

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1428-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1428-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-21
Z-1429-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-21
Z-1430-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-21
Z-1431-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-21

Product code DRI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)